Laser-cut clot puller

ABSTRACT

A device for removing blood clots and methods of making and using the same. The clot pulling device may include a first spine, a second spine disposed parallel to the first spine, and a basket disposed between and coupled to the spines. In addition, a pushing member may be coupled to the first spine and extend proximally therefrom.

FIELD OF THE INVENTION

The present invention pertains to intravascular medical devices. Moreparticularly, the present invention pertains to devices for capturingand removing blood clots from a blood vessel.

BACKGROUND

The present invention pertains generally to emboli collection andremoval.

Blood thrombus, may form a clot in a patient vasculature. Sometimes suchclots are harmlessly dissolved in the blood stream. At other times,however, such clots may lodge in a blood vessel where they can partiallyor completely occlude the flow of blood. If the partially or completelyoccluded vessel feeds blood to sensitive tissue such as, the brain,lungs or heart, for example, serious tissue damage may result.

When symptoms of an occlusion are apparent, such as an occlusionresulting in a stroke, immediate action should be taken to reduce oreliminate resultant tissue damage. One approach is to treat a patientwith clot dissolving drugs. These drugs, however, do not immediatelydissolve the clot from the patient.

BRIEF SUMMARY

The present invention pertains to devices for removing blood clots fromblood vessels. In at least some embodiments, a clot pulling deviceincludes a first spine, a second spine disposed generally parallel tothe first spine, and a basket disposed between and coupled to thespines. A pushing member may be coupled to the first spine and extendproximally therefrom. These and some of the other structural featuresand characteristics are described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial cross-sectional side view of an example medicaldevice disposed in a blood vessel;

FIG. 2 is a partial cross-sectional side view of an example medicaldevice disposed in a sheath within a blood vessel;

FIG. 3 is a perspective view of an example medical device;

FIG. 4 is a perspective view of the device in FIG. 3 in a collapsedconfiguration;

FIG. 5 is a perspective view of another example medical device; and

FIG. 6 is a perspective view of another example medical device.

DETAILED DESCRIPTION

The following description should be read with reference to the drawingswherein like reference numerals indicate like elements throughout theseveral views. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

For a number of reasons, it may be desirable to capture and/or removeclots from the vasculature. FIG. 1 is a partial cross-sectional sideview of an example clot pulling medical device 10 disposed in a bloodvessel 12. Blood vessel 12 can be essentially any vessel. Device 10 mayinclude two or more longitudinal spines, for example spines 14 a and 14b, a basket member or region 16 that is attached to or otherwise coupledwith spines 14 a/b, and a proximally-extending shaft or pushing member18. In general, device 10 can be advanced through the vasculature to asuitable location, for example adjacent a clot 20, and expanded so thatclot 20 can be captured in basket region 16. Device 10 and the capturedclot 20 can be removed from the vasculature.

Device 10 and/or basket region 16 may be configured to shift between afirst generally collapsed configuration and a second generally expandedconfiguration. In at least some embodiments, shifting between theseconfigurations includes the longitudinal movement of one or both ofspines 14 a/b relative to one another. Movement of spines 14 a/b mayoccur in either the proximal or distal direction and, in the case ofboth spines 14 a/b moving, may be in the same or opposite directions.For example, shifting may include the proximal or distal movement ofspine 14 b relative to spine 14 a. Shifting may also result in one orboth of spines 14 a/b moving somewhat laterally so that spines 14 a/bbecome closer to one another. This is because basket region 16 may be inthe expanded configuration when spines 14 a/b are generally alignedlongitudinally and disposed parallel to one another and, when basketregion 16 is collapsed, spines 14 a/b longitudinally move and movecloser to one another to allow basket region 16 to collapse to a lowerprofile (please see FIG. 2). It can be appreciated that longitudinallymoving spine 14 b and moving spines 14 a/b closer to one another mayelongate device 10, for example at basket region 16. Again, this may bedue to the fact that shifting the position of spines 14 a/b allows thebasket region 16 to shift between the expanded and collapsedconfiguration. Thus, collapsing basket region 16 may generally result inthe elongation of device 10.

Shifting between the collapsed and expanded configurations may occur ina number of differing manners. For example, device 10 or portionsthereof may be made of a shape-memory material (such as nickel-titaniumalloy) that can assume a pre-defined shape when unconstrained or whensubjected to particular thermal conditions. According to thisembodiment, device 10 can be manufactured to be “self-expanding” so thatit can be delivered in a collapsed configuration then shift to theexpanded configuration when a constraint is removed (e.g., a deliverysheath) or when device 10 is subject to the thermal conditions withinblood vessel 12. Alternatively, shifting may occur by mechanicallymoving one or both of spines 14 a/b. Moving spines 14 a/b may occur in anumber of different ways such as by moving shaft 18 or another shaft(for example shaft 27 as shown in FIG. 3) that may be, for example,attached to the distal end of device 10 and/or spine 14 b.

Spines 14 a/b may generally be connected to the proximal and distal endsof basket region 16, respectively, and be manufactured or otherwiseconfigured to be moved independently of one another. This may allowbasket region 16 to be easily collapsed by shifting the position ofspines 14 a/b. Additionally, because the collapsing of device 10 and/orbasket region 16 includes the longitudinal shifting of spines 14 a/b,outward radial forces are reduced. This may allow device 10 to moreeasily be disposed in or otherwise advance through sheath 22. Moreover,the length of spines 14 a/b can be altered so that collapsing forces andradial forces can be further reduced. For example, elongating spines 14a/b may reduce the forces needed to collapse device 10 and reduce radialforces.

When device 10 is in the collapsed configuration, it may be suited forbeing delivered via a suitable catheter or delivery sheath 22 as shownin FIG. 2. For example, it may be desirable to collapse device 10 anddispose it within sheath 22. Then, sheath 22 and device 10 can beadvanced to the desired position and sheath 22 can be proximallyretracted so that device 10 emerges therefrom and can shift to theexpanded configuration. Alternatively, device 10 can be delivered byfirst positioning sheath 22 at the desired location and then advancingdevice 10 through sheath 22. Removal of device 10 may be accomplished ina number of different ways. For example, device 10 may be removed bysimply retracting it proximally from the vasculature. Alternatively,device 10 may be retracted into or otherwise disposed in a suitableretrieval sheath or catheter.

In some embodiments, catheter or sheath 22 may be a microcatheter. Thedimensions and general configuration of the microcatheter can vary. Forexample, catheter 22 may have an inside lumen diameter of about 0.016 toabout 0.022 inches, or more or less. These dimensions may allow sheath22 to be suitably sized to access a number of different vascular targetswhile having a lumen sized sufficient to allow device 10 to advancethrough or otherwise be disposed therein. In addition or in thealternative, sheath 22 may include a distal housing section configuredfor having basket region 16 (or other portions of device 10) disposedtherein. Of course, a number of other delivery devices may be usedincluding essentially any suitable structure.

A perspective view of device 10 is shown in FIG. 3. Here it can be seenthat basket region 16 may include a plurality of loop structures 24extending between spines 14 a/b. The number, arrangement, andconfiguration of loops 24 may vary. For example, basket region 16 mayinclude two or more, three or more, four or more, five or more, and soforth sets of loops 24. Each set may include a single loop 24, a pair ofopposing loops 24 as shown in FIG. 3, or it may include three or moreloops 24 disposed in essentially any suitable pattern or arrangement.Some of examples of other suitable arrangements and variations aredescribed in more detail below.

As described above, device 10 may be configured so that basket region 16is self-expanding. Alternatively, basket region 16 may be expanded inother ways. For example, basket region 16 may be expanded bylongitudinally shifting a spine (e.g., spine 14 a) by pushing or pullingon shaft 18. In some embodiments, a second shaft 27 may be attachedadjacent the distal end of basket region 16, for example at the distalend of spine 14 b, and extend proximally. This second shaft 27 may allowa clinician to manipulate both of spines 14 a/b independently of oneanother by actuating either or both of shafts 18/27. It can beappreciated that any of the embodiments shown herein may include a shaftsimilar to shaft 27 if desired for collapsing and expanding the deviceor it's basket region.

The manufacturing of device 10 may include a number of different methodsand techniques. For example, device 10 may be manufactured bylaser-cutting, laser etching, chemical etching, or photo-chemicaletching a tubular structure so as to define spines 14 a/b and basketregion 16. In some embodiments, basket region 16 and spines 14 a/b canbe defined by laser-cutting a tubular structure such as a hypodermictube (i.e., a “hypotube”). This manufacturing method may be desirablefor a number of reasons. For example, this method may allow spines 14a/b and basket region 16 to be formed in a relatively simple manner,with relatively few manufacturing steps. Additionally, following thismethod may allow shaft 18 to be defined by the proximal region of thehypotube. Accordingly, the manufacturing method may be furthersimplified by not requiring any welding or attaching steps to connectvarious structures of device 10. In addition, forming device 10 from atubular structure may allow device to be passed over a guidewire orother guiding structure.

Alternatively, device 10 may be manufactured by cutting or forming theappropriate structures in a generally planar sheet of material and then,if necessary, attaching the ends of the planar structure or attachingone or more planar structures together in any suitable manner. Forexample, FIG. 3 shows an attachment point or weld line 26 in phantomline where the opposing sides of a sheet of material may be attached orwelded. In addition to being a weld, attachment point 26 may include andsuitable attachment such as an adhesive, a polymer strip, a thermalbond, a mechanical connection, etc.

It can be appreciated that most of the Figures depicting some of theembodiments of suitable clot pulling devices generally depict the basketregion 16 as being at the distal end of device 10. However, this neednot be the case. For example, some embodiments may include a basketregion 16 that is generally disposed a distance proximal of the distalend of device 10. A number of different manufacturing methods may beemployed in order to build such a device. For example, basket region 16may be laser cut (or cut in any suitable manner) into device 10 at thedesired position of a tubular structure such as a hypotube.Alternatively, basket region 16 may be made in a suitable way (such asby cutting a hypotube, forming a braid or helix having the desiredstructure, etc.) and then be attached to shafts or tubular structures onopposite ends thereof. Regardless of how this type of device ismanufactured, it may still be possible to shift basket region 16 betweenthe collapsed and expanded configurations in a manner similar to what isdescribed herein. For example, basket region 16 may be made from a shapememory material or otherwise be self-expanding. Alternatively, one ormore shafts (e.g., shaft 18/27) may be attached adjacent the proximaland distal ends of basket region 16 so that spines 14 a/b can be movedand so that basket region 16 can be expanded and collapsed.

As described above, all or portions of device 10 may be manufacturedfrom materials such as nickel titanium alloy. However, any suitablematerial may be used including metals, metal alloys, polymers, etc. Someexamples of suitable metals and metal alloys include stainless steel,such as 304V, 304L, and 316L stainless steel; linear-elastic orsuper-elastic nitinol or other nickel-titanium alloys, nickel-chromiumalloy, nickel-chromium-iron alloy, cobalt alloy, tungsten or tungstenalloys, MP35-N (having a composition of about 35% Ni, 35% Co, 20% Cr,9.75% Mo, a maximum 1% Fe, a maximum 1% Ti, a maximum 0.25% C, a maximum0.15% Mn, and a maximum 0.15% Si), hastelloy, monel 400, inconel 825, orthe like; or other suitable material.

Some examples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM), polybutylene terephthalate(PBT), polyether block ester, polyurethane, polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example a polyether-esterelastomer such as ARNITEL® available from DSM Engineering Plastics),polyester (for example a polyester elastomer such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), silicones, polyethylene (PE), Marlexhigh-density polyethylene, Marlex low-density polyethylene, linear lowdensity polyethylene (for example REXELL®), polyethylene terephthalate(PET), polyetheretherketone (PEEK), polyimide (PI), polyetherimide(PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO),polysulfone, nylon, perfluoro(propyl vinyl ether) (PFA), other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments portions or all of device10 can be blended with a liquid crystal polymer (LCP). For example, themixture can contain up to about 5% LCP.

In some embodiments, a coating, for example a lubricious, a hydrophilic,a protective, or other type of coating may be applied over portions orall device 10. Hydrophobic coatings such as fluoropolymers provide a drylubricity which improves device exchanges. Lubricious coatings improvesteerability and improve lesion crossing capability. Suitable lubriciouspolymers are well known in the art and may include silicone and thelike, hydrophilic polymers such as polyarylene oxides,polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics,algins, saccharides, caprolactones, and the like, and mixtures andcombinations thereof. Hydrophilic polymers may be blended amongthemselves or with formulated amounts of water insoluble compounds(including some polymers) to yield coatings with suitable lubricity,bonding, and solubility. Some other examples of such coatings andmaterials and methods used to create such coatings can be found in U.S.Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein byreference. In some embodiments, the sheath or coating may be appliedover basket region 16. This may provide extra surface area to containclots that might be captured therein.

The sheath or polymeric layer coating may be formed, for example, bycoating, by extrusion, co-extrusion, interrupted layer co-extrusion(ILC), or fusing several segments end-to-end. The layer may have auniform stiffness or a gradual reduction in stiffness from the proximalend to the distal end thereof. The gradual reduction in stiffness may becontinuous as by ILC or may be stepped as by fusing together separateextruded tubular segments. The outer layer may be impregnated with aradiopaque filler material to facilitate radiographic visualization.Those skilled in the art will recognize that these materials can varywidely without deviating from the scope of the present invention.

Device 10, or portions thereof, may also be coated, plated, wrapped orsurrounded by, doped with, or otherwise include a radiopaque material.For example, spines 14 a/b and/or basket region 16 may be made from aradiopaque material or may include a radiopaque marker member or coilcoupled thereto. Radiopaque materials are understood to be materialscapable of producing a relatively bright image on a fluoroscopy screenor another imaging technique during a medical procedure. This relativelybright image aids the user of device 10 in determining its location.Some examples of radiopaque materials can include, but are not limitedto, gold, platinum, palladium, tantalum, tungsten alloy, plasticmaterial loaded with a radiopaque filler, and the like.

In some embodiments, a degree of MRI compatibility may be imparted intodevice 10. For example, to enhance compatibility with Magnetic ResonanceImaging (MRI) machines, it may be desirable to make portions of device10, in a manner that would impart a degree of MRI compatibility. Forexample, device 10, or portions thereof, may be made of a material thatdoes not substantially distort the image and create substantialartifacts (artifacts are gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an MRI image. Device 10, or portions thereof, may also bemade from a material that the MRI machine can image. Some materials thatexhibit these characteristics include, for example, tungsten, Elgiloy,MP35N, nitinol, and the like, and others.

A perspective view of device 10 in the collapsed (or nearly collapsed)configuration is shown in FIG. 4. Here it can be seen how spine 14 b mayextend distally beyond the distal end of spine 14 a when basket region16 is collapsed. It can also be seen that as basket region 16 iscollapsed, its structure begins to resemble that of a tube, for example,a hypotube from which device 10 has been manufactured from.

As seen in FIGS. 1-4, both the proximal and distal ends of basket region16 may be generally “open” so that a clot can captured by passing theclot into either end of basket region 16. It is not necessary, however,to have both ends of basket region 16 open. For example, FIG. 5illustrates device 110 that is similar to device 10 except that device110 includes an end loop 128 that “closes” one of the ends of basketregion 116 (in this case the distal end of basket 116). Thisconfiguration may be desirable by allowing device 110 to capture a clotwithin basket region 116 while decreasing the possibility that the clotwill pass out of the other end of basket region 116. Accordingly, basketregion 116 may include both loops 124 and end loop 128 that,collectively, define basket region 116 that has a somewhat cylindricalor conical shape.

In general, end loop 128 may extend between spines 114 a/b and may beslightly curved in order to allow shifting of the position of spines 114a/b in a manner similar to what is described above. Although end loop128 is depicted in FIG. 5 to be at the distal end of basket region 116,this need not be the case. For example, end loop 128 may be positionednear the proximal end of basket region 116 (i.e., adjacent shaft 118).

FIG. 6 illustrates device 210 that is similar to devices 10 and 110except that device 210 includes side rails or spines 230 a/b and loops224 a/b/c/d/e that are spaced are various distances. Accordingly, anumber of features attributable to this and other embodiments can beseen. For example, by including side rails 230 a/b, which may be orresemble spines 214 a/b, it can be seen that the number of spines mayvary from two, three, four or more. Additionally, basket 216 (as well asother basket regions described herein) may includes loops 224 a/b/c/d/ethat vary number, shape, and configuration. For example, FIG. 6illustrates that device 10 may include five sets of loops 224 a/b/c/d/e.However, any suitable number of loops 224 a/b/c/d/e may includedincluding two, three, four, five, six, or more.

It can also be seen in FIG. 6 that the pattern or arrangement of loops224 a/b/c/d/e may vary. For example, the distance between loop 224 a andloop 224 b may vary greatly and could be about 0.008 to about 0.020inches or more or less. The spacing between loop 224 b and loop 224 c(as well as between loop 224 c and loop 224 d, and between loop 224 dand loop 224 e) may be different from the previously mentioned spacing.The overall length of basket region 216 may also vary. For example,basket region may have a length in the range of about 1 to about 15millimeters or more or less.

Device 210 can be made and used similar to what is described above. Forexample, device 210 may be delivered using a suitable delivery device(e.g., sheath 22). Basket region 216 may be configured to shift betweenthe collapsed and expanded configuration in essentially any of the waysdescribed above. For example, basket region 216 may be self-expanding orit may be expandable by actuating shaft 218.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. A medical device for removing clots from a blood vessel, comprising:a first longitudinally-oriented spine having a distal end; a pushingmember coupled to the proximal end of the first longitudinally-orientedspine and extending proximally therefrom; and a clot-grabbing basketgenerally disposed between and coupled to the firstlongitudinally-oriented spine.
 2. The medical device of claim 1, whereinthe basket includes a proximal end and a distal end and wherein thedistal end is attached to the first longitudinally-oriented spine andthe proximal end is attached to the first longitudinally-oriented spine.3. The medical device of claim 2, wherein the proximal end of the basketis open.
 4. The medical device of claim 2, wherein the distal end of thebasket is open.
 5. The medical device of claim 2, wherein both theproximal end and the distal end of the basket are open.
 6. The medicaldevice of claim 1, wherein the first longitudinally-oriented spineincludes a nickel-titanium alloy.
 7. The medical device of claim 1,wherein the basket includes a nickel-titanium alloy.
 8. The medicaldevice of claim 1, where in the basket is adapted to shift between afirst generally collapsed configuration and a second generally expandedconfiguration.
 9. The medical device of claim 8, wherein the basket isbiased to be in the second configuration.
 10. The medical device ofclaim 8, wherein the basket is biased to be in the first configuration,and the basket is shifted to the second configuration using a pull wire.11. The medical device of claim 8, wherein the basket is shifted fromthe first configuration toward the second configuration by distallyadvancing the pushing member.
 12. The medical device of claim 8, whereinthe basket includes a shape memory material and wherein the basket canbe shifted between the first configuration and the second configurationby altering the temperature of the basket.
 13. The medical device ofclaim 8, further comprising a second longitudinally-oriented spine,wherein the first longitudinally-oriented spine and the secondlongitudinally-oriented spine are closer together when the basket is inthe first configuration and the first longitudinally-oriented spine andthe second longitudinally-oriented spine move further apart when thebasket shifts toward the second configuration.
 14. The medical device ofclaim 1, wherein at least one of the first longitudinally-orientedspine, and basket include a marker member coupled thereto.
 15. A medicaldevice, comprising: a clot-pulling device including a first spine, asecond spine generally parallel to the first spine, and a basket coupledto and disposed therebetween; a shaft coupled to the first spine andextending proximally therefrom; and an elongate catheter for deliveringthe clot-pulling device.
 16. The medical device of claim 15, wherein thecatheter includes a distal housing configured for having theclot-pulling device disposed therein.
 17. The medical device of claim15, wherein the catheter includes a lumen extending along the lengththereof for advancing the clot-pulling device therethrough.
 18. A methodfor removing clots from a blood vessel, comprising the steps of:providing a clot pulling device including a first spine having aproximal end, a second spine disposed parallel to the first spine, apushing member coupled to the proximal end of the first spine andextending proximally therefrom, and a basket disposed between andcoupled to the first and second spines; providing a catheter having alumen extending therethrough; advancing the catheter through a bloodvessel to a location adjacent an area of interest; advancing the clotpulling device through the lumen of the catheter to a position distallyof the area of interest; expanding the basket; and entrapping a clotwithin the basket.
 19. The method of claim 18, wherein the step ofadvancing the catheter through a blood vessel to a location adjacent anarea of interest includes disposing the clot pulling device in the lumenand advancing the catheter and clot pulling device through the bloodvessel.
 20. The method of claim 19, wherein the step of advancing theclot pulling device through the lumen of the catheter to a positiondistally of the area of interest includes advancing the clot pullingdevice out from a distal end of the catheter.
 21. The method of claim19, wherein the step of advancing the clot pulling device through thelumen of the catheter to a position distally of the area of interestincludes pushing the clot pulling in the distal direction with thepushing member.
 22. The method of claim 18, wherein the step ofexpanding the basket includes applying force in the distal direction tothe pushing member.
 23. A method for removing clots from a blood vessel,comprising the steps of: providing a clot pulling device including afirst spine having a proximal end, a second spine disposed parallel tothe first spine, a pushing member coupled to the proximal end of thefirst spine and extending proximally therefrom, and a basket disposedbetween and coupled to the first and second spines; providing a catheterhaving a lumen extending therethrough; disposing the clot pulling devicewithin the lumen of the catheter; advancing the catheter through a bloodvessel to a location adjacent an area of interest; proximally retractingthe catheter relative to the clot pulling device; expanding the basket;and entrapping a clot within the basket.
 24. The method of claim 23,wherein the basket is self expanding so that the steps of proximallyretracting the catheter relative to the clot pulling device andexpanding the basket are combined into a single step.
 25. The method ofclaim 23, wherein the step of expanding the basket includes applyingforce in the distal direction to the pushing member.